NCT05088824

Brief Summary

One of the most significant subjects studied in abdominal wall surgery is inguinal hernia. Its management is very codified. The main factors evaluating efficient hernia surgery are not only the rate of complications (recurrence and groin pain essentially) but also cost and time to return to normal activities. Desarda technique is a non-mesh technique described first in 2001. This surgical technique uses a flap of external oblique aponeurosis in place of a mesh. Its singularity remains its low cost, no use of mesh, and less extensive dissection Mesh repair has its own limitations; it is unphysiological as mesh is used. Chronic inguinal pain, seroma formation, foreign body sensation, risk of mesh infection are common complications and not recommended in strangulated hernias and extra cost involved by the mesh itself. It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles. This is a physiological repair and is tension free, can be used in strangulated hernia. Recurrence and complication rates equal to or less than Lichtenstein's repair. It's a simple procedure, early ambulation and less time of hospital stay, low cost for the patient as mesh is not used and most importantly no question of mesh related complications such as mesh rejection, infection, migration and foreign body sensation and chronic groin pain which is comparatively low in this procedure.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

September 24, 2021

Last Update Submit

October 9, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • postoperative hospital stay

    the duration of postoperative hospital stay

    6 month

  • chronic pain

    the patient will be assed for the presence of feeling of pain after the procedure or not

    6 months

  • recurrence

    the patient will be followed up for recurrence of hernia in the same place by clinical examination

    6 months

Study Arms (1)

patients diagnosed with oblique inguinal hernia

Procedure: hernia repair by desarda technique

Interventions

It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles. This is a physiological repair and is tension free, can be used in strangulated hernia

patients diagnosed with oblique inguinal hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A prospective clinical trial will be conducted on 30 patients diagnosed with oblique inguinal hernia . The study population will go for hernia repair by Desarda technique . The treatment will be herniorrhaphy. All the patients will be followed up after the 1st week, 1st month, 3 month and after 6 month . The efficacy and adverse effects will be compared by statistical analysis.

You may qualify if:

  • primary inguinal hernia
  • Aged 18 and above
  • reducible inguinal or inguino-scrotal hernia

You may not qualify if:

  • Obstructive uropathy or chronic obstructive pulmonary disease
  • incarcerated hernia
  • recurrent hernia
  • bilateral hernia
  • active infection at groin area
  • pantalloon hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

boshra N. boshra, resident

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 22, 2021

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

October 22, 2021

Record last verified: 2021-10